Vaginal Atrophy
Conditions
Keywords
Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
Brief summary
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Interventions
DRUGPlacebo
Placebo vaginal suppository
DRUGDHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA
Sponsors
EndoCeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women (non-hysterectomized or hysterectomized) * Women between 40 and 75 years of age * Willing to participate in the study and sign an informed consent * Women who have self-identified symptom(s) of vaginal atrophy * For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study
Exclusion criteria
* Undiagnosed abnormal genital bleeding * Hypertension equal to or above 140/90 mm Hg * The administration of any investigational drug within 30 days of screening visit * Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline and Week 12 | The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline and Week 12 | The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Vaginal pH | Baseline and Week 12 | A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline and Week 12 | The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Severity of Dyspareunia | Baseline and Week 12 | The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline and Week 12 | To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. | 150 |
| 0.25% DHEA DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. | 143 |
| 0.50% DHEA DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. | 148 |
| Total | 441 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 3 |
| Overall Study | Entry criteria not met/Non-compliance | 12 | 12 | 16 |
| Overall Study | Lost to Follow-up | 1 | 1 | 3 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 2 |
Baseline characteristics
| Characteristic | 0.25% DHEA | 0.50% DHEA | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 58.41 years STANDARD_DEVIATION 6.02 | 58.33 years STANDARD_DEVIATION 6.16 | 57.59 years STANDARD_DEVIATION 6.47 | 58.11 years STANDARD_DEVIATION 6.22 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 13 Participants | 12 Participants | 34 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White caucasian | 132 Participants | 131 Participants | 135 Participants | 398 Participants |
| Sex/Gender, Customized Female | 143 Participants | 148 Participants | 150 Participants | 441 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 150 | 17 / 143 | 23 / 148 |
| serious Total, serious adverse events | 5 / 150 | 1 / 143 | 1 / 148 |
Outcome results
Primary
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 60.66 percentage of parabasal cells | Standard Error 3.4 |
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 1.56 percentage of parabasal cells | Standard Error 1.98 |
| Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 62.22 percentage of parabasal cells | Standard Error 3.49 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 56.74 percentage of parabasal cells | Standard Error 3.69 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | -17.51 percentage of parabasal cells | Standard Error 2.74 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 39.23 percentage of parabasal cells | Standard Error 3.15 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | -26.52 percentage of parabasal cells | Standard Error 2.94 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Week 12 | 33.02 percentage of parabasal cells | Standard Error 3.09 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | Baseline | 59.54 percentage of parabasal cells | Standard Error 3.41 |
Primary
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 1.80 percentage of superficial cells | Standard Error 0.29 |
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 0.97 percentage of superficial cells | Standard Error 0.13 |
| Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 0.83 percentage of superficial cells | Standard Error 0.26 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 3.43 percentage of superficial cells | Standard Error 0.34 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 1.12 percentage of superficial cells | Standard Error 0.13 |
| 0.25% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 2.31 percentage of superficial cells | Standard Error 0.32 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Baseline | 0.93 percentage of superficial cells | Standard Error 0.11 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Change from Baseline to Week 12 | 2.66 percentage of superficial cells | Standard Error 0.41 |
| 0.50% DHEA | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | Week 12 | 3.58 percentage of superficial cells | Standard Error 0.41 |
Primary
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Week 12 | 1.27 Severity score | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline | 2.38 Severity score | Standard Error 0.04 |
| Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Change from Baseline to Week 12 | -1.12 Severity score | Standard Error 0.08 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Week 12 | 1.10 Severity score | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline | 2.37 Severity score | Standard Error 0.04 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Change from Baseline to Week 12 | -1.28 Severity score | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Baseline | 2.35 Severity score | Standard Error 0.04 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Change from Baseline to Week 12 | -1.22 Severity score | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness | Week 12 | 1.13 Severity score | Standard Error 0.08 |
Primary
Change From Baseline to Week 12 in Vaginal pH
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.28 pH units | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 6.06 pH units | Standard Error 0.08 |
| Placebo | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.34 pH units | Standard Error 0.05 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 5.69 pH units | Standard Error 0.09 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.27 pH units | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.58 pH units | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Baseline | 6.29 pH units | Standard Error 0.06 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Change from Baseline to Week 12 | -0.62 pH units | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Vaginal pH | Week 12 | 5.67 pH units | Standard Error 0.08 |
Secondary
Change From Baseline to Week 12 in Severity of Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses on dyspareunia were performed on a subgroup of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe dyspareunia at Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Dyspareunia | Week 12 | 1.78 Severity score | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 12 in Severity of Dyspareunia | Baseline | 2.56 Severity score | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Dyspareunia | Change from Baseline to Week 12 | -0.78 Severity score | Standard Error 0.1 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Week 12 | 1.48 Severity score | Standard Error 0.12 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Baseline | 2.58 Severity score | Standard Error 0.05 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Change from Baseline to Week 12 | -1.10 Severity score | Standard Error 0.12 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Baseline | 2.60 Severity score | Standard Error 0.05 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Change from Baseline to Week 12 | -1.06 Severity score | Standard Error 0.1 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Dyspareunia | Week 12 | 1.54 Severity score | Standard Error 0.1 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.31 Severity score | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.66 Severity score | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.35 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.16 Severity score | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.60 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.45 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Baseline | 2.65 Severity score | Standard Error 0.06 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Change from Baseline to Week 12 | -0.53 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | Week 12 | 2.12 Severity score | Standard Error 0.06 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.94 Severity score | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.32 Severity score | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.38 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.74 Severity score | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.19 Severity score | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.46 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Baseline | 2.19 Severity score | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Change from Baseline to Week 12 | -0.50 Severity score | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | Week 12 | 1.69 Severity score | Standard Error 0.07 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.40 Severity score | Standard Error 0.07 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.78 Severity score | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Change from Baseline to Week 12 | -0.38 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.25 Severity score | Standard Error 0.07 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.66 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Change from Baseline to Week 12 | -0.40 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Baseline | 2.72 Severity score | Standard Error 0.06 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Change from Baseline to Week 12 | -0.56 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | Week 12 | 2.16 Severity score | Standard Error 0.06 |
Secondary
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time frame: Baseline and Week 12
Population: Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 2.33 Severity score | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.71 Severity score | Standard Error 0.05 |
| Placebo | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.38 Severity score | Standard Error 0.05 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 2.07 Severity score | Standard Error 0.08 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.55 Severity score | Standard Error 0.06 |
| 0.25% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.48 Severity score | Standard Error 0.08 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Baseline | 2.55 Severity score | Standard Error 0.06 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Change from Baseline to Week 12 | -0.48 Severity score | Standard Error 0.07 |
| 0.50% DHEA | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | Week 12 | 2.07 Severity score | Standard Error 0.06 |